3,099 results
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32ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PLATE, FIXATION, BONE
FDA Adverse Event
Malfunction
·SYNTHES (USA)·Product code HRS·March 13, 2014
Carestream Vue PACS; UNLIMITED READING LIC ADD 100K E/YR The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
FDA Enforcement
Class II
·Terminated·Carestream Health Inc.·November 20, 2013
COBAS PRO ISE ANALYTICAL UNIT
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·February 11, 2026
ANATOMIC RADIAL HEAD SYSTEM
FDA Adverse Event
Injury
·ACUMED, LLC·Product code KWI·August 20, 2025
ANATOMIC RADIAL HEAD SYSTEM
FDA Adverse Event
Injury
·ACUMED, LLC·Product code KWI·August 21, 2025
ANATOMIC RADIAL HEAD SYSTEM
FDA Adverse Event
Injury
·ACUMED, LLC·Product code KWI·August 20, 2025
ANATOMIC RADIAL HEAD SYSTEM
FDA Adverse Event
Injury
·ACUMED, LLC·Product code KWI·August 21, 2025
ANATOMIC RADIAL HEAD SYSTEM
FDA Adverse Event
Injury
·ACUMED, LLC·Product code KWI·August 21, 2025
ANATOMIC RADIAL HEAD SYSTEM
FDA Adverse Event
Injury
·ACUMED, LLC·Product code KWI·August 20, 2025
ANATOMIC RADIAL HEAD SYSTEM
FDA Adverse Event
Injury
·ACUMED, LLC·Product code KWI·August 21, 2025
ANATOMIC RADIAL HEAD SYSTEM
FDA Adverse Event
Injury
·ACUMED, LLC·Product code KWI·August 20, 2025
ANATOMIC RADIAL HEAD SYSTEM
FDA Adverse Event
Injury
·ACUMED, LLC·Product code KWI·August 21, 2025
ANATOMIC RADIAL HEAD SYSTEM
FDA Adverse Event
Injury
·ACUMED, LLC·Product code KWI·August 20, 2025
UNKNOWN GAMMA 4 HIP LAG SCREW
FDA Adverse Event
Injury
·STRYKER GMBH·Product code HSB·June 7, 2025
GAMMA4 - TROCHANTERIC NAIL 170MM D12X170MM X 125DEG
FDA Adverse Event
Injury
·STRYKER GMBH·Product code HSB·June 7, 2025
Carestream Vue PACS; UNLIMITED READING LIC ADD 100K E/YR The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
FDA Recall
Terminated
·Carestream Health Inc.·Product code LLZ·September 16, 2013
Tourniquet, Gastro-Urology
FDA classification
FDA Class 1
·Tourniquet, Gastro-Urology
3Shape Scan Bodies
FDA UDI
3shape Trios A/S·05902729751681·ANKYLOS - Regular platform - Connection: Ø3,5
HU-FRIEDY
FDA UDI
HU-FRIEDY MFG. CO., LLC·10889950009243·#4R Seldin Elevator
HU-FRIEDY
FDA UDI
HU-FRIEDY MFG. CO., LLC·10889950009007·#1R Seldin Elevator